BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 3203480 · Received July 2, 2013

    Report

    Report Number
    2032227-2013-02717
    Event Type
    Injury
    Date Received
    July 2, 2013
    Date of Event
    June 5, 2013
    Report Date
    June 9, 2013
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    A COMPLETE ANALYSIS AND TESTING OF THE INSULIN PUMP SHOWED THAT IT WAS FUNCTIONING PROPERLY AND PASSED ALL FUNCTIONAL TESTING. AFTER TESTING, IT WAS CONCLUDED THAT THE DEVICE OPERATED WITHIN SPECIFICATIONS. THE INSULIN PUMP HAD A BROKEN RESERVOIR TUBE LIP.

    Description of Event or Problem · 1

    THE CUSTOMER STATED THAT SHE WAS HOSPITALIZED FOR DIABETIC KETOACIDOSIS, AND WAS TOLD THE INSULIN PUMP NEEDS TO BE REPLACED. THE BLOOD GLUCOSE READING WAS 746 MG/DL. THE CUSTOMER EXPERIENCED KETONES, DEHYDRATION, AND HER ELECTROLYTES WERE OFF BALANCE. THE CUSTOMER DIDN'T FEEL THAT THE INSULIN PUMP MALFUNCTIONED, BUT SHE STATED SHE WON'T BE RELEASED IF SHE DOESN'T GET IT REPLACED. THE CUSTOMER MENTIONED THAT THE INSULIN PUMP HAS A CRACK ON THE RESERVOIR COMPARTMENT. ADVISED THE CUSTOMER THAT THE INSULIN PUMP WOULD BE REPLACED. NOTHING FURTHER WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    302763 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC MINIMED MMT-523LNAS

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR Hospitalization